This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, Denmark
Change in the degree of inflammation in the knee-joint (DCE-MRI)
Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)
Time frame: Week 0 to 52
Change in the degree of inflammation in the knee-joint (CE-MRI)
Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.)
Time frame: Week 0 to 52
Change in the degree of inflammation in the knee-joint (MRI)
Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)
Time frame: Week 0 to 52
Change in cartilage composition
Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)
Time frame: Week 0 to 52
Change in bone marrow lesions
Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score
Time frame: Week 0 to 52
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